Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee
NCT ID: NCT00589979
Last Updated: 2017-10-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
169 participants
INTERVENTIONAL
2007-03-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Lidoderm (Lidocaine 5% Patch)
Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h)
Lidoderm (Lidocaine 5% Patch)
Topical Patch
Placebo Patch
Placebo Patch 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h)
Placebo Patch
Topical Patch
Interventions
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Lidoderm (Lidocaine 5% Patch)
Topical Patch
Placebo Patch
Topical Patch
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) ≤40 kg/m2
* Symptomatic OA of the index knee diagnosed with a functional capacity of II or III according to ACR criteria classification Note: Patients with symptomatic contralateral knee OA with persistent pain ≤2 cm on a 0-10 cm PI-NRS for ≥2 months will be allowed to participate.
* Unchanged dose of analgesic medication for OA for at least 4 weeks prior to screening and for the duration of the study
* Able and willing to complete all paper and e-diary assessments required by protocol
Exclusion Criteria
* Compromised integrity of the intact, superficial skin layer
* A grade 1 or 4 Kellgren and Lawrence score on radiographic examination
* Recent injury to either knee causing pain and interference with daily activities (eg. walking)
* Recent surgery/procedure to either knee causing pain that could interfere with study assessments of pain, function, and QoL
* Known hypersensitivity or allergy to lidocaine, local anesthetics of the amide type, or any component of the product
37 Years
ALL
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Ernest A. Kopecky, PhD, MBA
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
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Arizona Arthritis Research, PLC
Paradise Valley, Arizona, United States
NextCare Institute for Clinical Research
Phoenix, Arizona, United States
HOPE Research Institute, LLC
Phoenix, Arizona, United States
Clinical Research Consulting
Milford, Connecticut, United States
New England Research Associates, LLC
Trumbull, Connecticut, United States
Tampa Bay Medical Research, Inc.
Clearwater, Florida, United States
Delray Research Associates
Delray Beach, Florida, United States
CNS Clinical Trials
St. Petersburg, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Arthritis & Osteoporosis Center of Maryland
Frederick, Maryland, United States
Midwest Pharmaceutical Research
City of Saint Peters, Missouri, United States
Arthritis Center of Nebraska
Lincoln, Nebraska, United States
Comprehensive Clinical Research
Berlin, New Jersey, United States
University Hospitals of Case Medical Center - Arthritis Translational Research Program
Beachwood, Ohio, United States
Community Research
Cincinnati, Ohio, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Health Concepts
Rapid City, South Dakota, United States
Radiant Research
San Antonio, Texas, United States
Advanced Pain Management & Rehabilitation, Hilltop Medical
Virginia Beach, Virginia, United States
Countries
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Other Identifiers
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EN3260-003
Identifier Type: -
Identifier Source: org_study_id